Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205858
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZYDELIG | IDELALISIB | 100MG | TABLET;ORAL | Prescription | None | Yes | No |
ZYDELIG | IDELALISIB | 150MG | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/23/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/06/2022 | SUPPL-18 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s018ltr.pdf |
03/10/2022 | SUPPL-17 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s017ltr.pdf |
02/18/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s016ltr.pdf | |
10/19/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205858Orig1s014ltr.pdf | |
10/10/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s013ltr.pdf | |
03/22/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s012ltr.pdf |
02/02/2018 | SUPPL-11 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s011ltr.pdf | |
02/06/2018 | SUPPL-10 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s010ltr.pdf |
01/26/2018 | SUPPL-9 | Labeling-Package Insert, REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s009ltr.pdf | |
11/29/2017 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s007ltr.pdf | |
01/04/2017 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s005ltr.pdf |
09/21/2016 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf | |
01/19/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/01/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/18/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf | |
10/19/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf | |
10/19/2020 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf | |
10/10/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf | |
02/02/2018 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf | |
01/26/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf | |
01/26/2018 | SUPPL-9 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf | |
11/29/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf | |
09/21/2016 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf | |
09/21/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf | |
07/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf |